European anti-counterfeiting plans approved

Plans to change prescription drug packaging to enable pharmacists and the supply chain to check the authenticity of individual medicine packs have been approved by the European Parliament.

The moves will see medicines given new safety features that could include a serialisation number on individual packs, which would be read electronically in pharmacies.

The NPA called the directive "one of the most significant" ever seen for community pharmacies, and warned the changes must be implemented "in an efficient and non-bureaucratic way".

The directive, approved by MEPs on February 16, will also see online medicines sales regulated at a European level for the first time, with a planned common logo for all European internet pharmacies.

And it said all member states must have a robust strategy to prevent counterfeits reaching patients.

"This is one of the most significant European directives for community pharmacy that we have ever seen and its impact will be felt by pharmacists working across the EU," said Raj Patel, NPA board member and head of the UK delegation to the Pharmaceutical Group of the European Union (PGEU).

"It is important that we see a risk-based and proportionate implementation of this directive – protecting patients but not introducing unnecessary bureaucracy," he added.

Many of the details of electronic verification are left to be determined by the European Commission, including the type of unique identifier to be attached to medicines packs and the organisation of databases to support the system, the PGEU said.

But the group warned that it had "serious reservations" about the use of a common logo for internet pharmacies.

"Such logos are easily counterfeited, and may provide a false sense of security for patients unless they are technically very robust," the pharmaceutical group said.

However, PGEU secretary general John Chave agreed most of the proposals to combat internet sales of counterfeit medicines were "measured and sensible".

"This is in many ways a radical directive, which will have considerable impact on the European medicines supply chain," he said.

"It seems certain that at some point in the coming years European pharmacists will verify the authenticity of a medicine before it is dispensed."

The directive is still awaiting formal approval from the Council of Ministers. A full version of the proposals is available here.